Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474214
Status:
COMPLETED
Last Update Posted:
2010-02-23
First Post:
2007-05-15
Brief Title:
Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-risk Primary Percutaneous Coronary Intervention PCI Patients
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-risk Primary PCI Patients The SAFE-DEPART Trial
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFE-DEPART
Brief Summary:
The purpose of this study is to determine if early hospital discharge at 48-72 hours is feasible safe cost-effective andor improves compliance with medications positive lifestyle changes and quality-of-life in low-risk patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention primary PCI
Detailed Description:
Patients with acute ST-segment elevation myocardial infarction STEMI have traditionally been hospitalized for at least 5-7 days to monitor for serious complications including heart failure arrhythmias re-infarction and death With the advent of primary percutaneous coronary intervention PCI as the treatment of choice for STEMI fewer patients are completing their infarcts and the incidence of complications is decreasing The Zwolle Primary PCI Index is one of several externally validated risk scores that can be used to identify low-risk primary PCI patients who can safely be discharged at 48-72 hours Recent reviews have found that a majority of primary PCI patients with risk scores that deem them low-risk are kept in hospital longer than predicted by these scores
SAFE-DEPART is a trial where low-risk primary and rescue PCI patients will be randomized either to an intervention arm early hospital discharge early outpatient follow-up with a nurse practitioner or to standard of care no recommended discharge date no outpatient follow-up with a nurse practitioner At 6 weeks time a blinded research assistant will contact patients and collect data on feasibility safety quality-of-life and cost-effectiveness outcomes
SAFE-DEPART is a trial where low-risk primary and rescue PCI patients will be randomized either to an intervention arm early hospital discharge early outpatient follow-up with a nurse practitioner or to standard of care no recommended discharge date no outpatient follow-up with a nurse practitioner At 6 weeks time a blinded research assistant will contact patients and collect data on feasibility safety quality-of-life and cost-effectiveness outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None